Approved by the FDA in 1989, spinal cord stimulation (SCS) has become a standard treatment for patients with chronic pain in their back and/or limbs who have not found pain relief from other treatments. In general, neurostimulation works by applying an electrical current to nerve tissue in the pathway of the chronic pain. This creates a pleasant sensation that blocks the brain's ability to sense the previously perceived pain. There are two conventional forms of electrical stimulation commonly used to treat chronic pain: Spinal Cord Stimulation (SCS) and Peripheral Nerve Field Stimulation (PNFS). In spinal cord stimulation, electrical leads are placed onto the spinal column. A programmable pulse generator is implanted in the upper buttock or abdomen (under the skin) which emits electrical currents to the spinal column. Peripheral nerve field stimulation is similar to spinal cord stimulation, however peripheral nerve field stimulation involves placing the leads just under the skin in an area near to the nerves involved in pain.
In both approaches, the implantable pulse generator (IPG) can be programmed with the use of an external programmer. Such programming currently requires the interaction of two individuals: the programming person and the patient. The programming person is typically a company representative of the IPG manufacturer or a member of the clinical staff. The programming person manually adjusts the various stimulus parameters with the use of the external programmer. The patient gives feedback to the programming person as the person cycles through the parameters. Thus, after every parameter change made by the programming person, they must ask the patient for efficacy feedback. This use of personnel is expensive and time consuming, particularly for clinical staff who currently do not have insurance reimbursement codes for such tasks.
Efforts to reduce programming time have been made by preparing pre-made program stimulation “sets” (i.e. pre-defined amplitude, pulse width, repetition rate, etc). The stimulation sets are then presented to the patient in a randomized order. The patient responds to each set regarding its efficacy. After the patient feedback has been collected, the data is presented to the physician who makes the decision as to which stimulation set to assign to the patient. However, this methodology reduces the programming options to a very small subset of the possible parameter combinations. The likelihood of the patient's pain profile matching a premade set is relatively low.
Thus, it is desired to provide devices, systems and methods which allow individualized programming of a stimulator for a given patient while reducing and preferably minimizing time and cost. Such devices, systems and methods should improve and preferably optimize the programming parameters while more fully utilizing the capabilities of the stimulator. At least some of these objectives will be met by embodiments of the present invention.